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Aventis CropScience; Availability of Determination of Nonregulated Status for Cotton Genetically Engineered for Glufosinate Herbicide Tolerance

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Information about this document as published in the Federal Register.

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Animal and Plant Health Inspection Service, USDA.




We are advising the public of our determination that the Aventis CropScience cotton designated as Transformation Event LLCotton25, which has been genetically engineered for tolerance to the herbicide glufosinate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Aventis CropScience in its petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice. This Start Printed Page 13893notice also announces the availability of our written determination and our finding of no significant impact.


March 10, 2003.


You may read a copy of the determination, an environmental assessment and finding of no significant impact, the petition for a determination of nonregulated status submitted by Aventis CropScience, and all comments received on the petition and the environmental assessment in our reading room. The reading room is located in room 1141, USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure that someone is available to help you, please call (202) 690-2817 before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at​ppd/​rad/​webrepor.html.

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Dr. Susan Koehler, Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the determination or environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail:

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On February 12, 2002, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 02-042-01p) from Aventis CropScience (Aventis) of Research Triangle Park, NC, requesting a determination of nonregulated status under 7 CFR part 340 for cotton (Gossypium hirsutum L.) designated as Transformation Event LLCotton25 (LLCotton25), which has been genetically engineered for tolerance to the herbicide glufosinate. The Aventis petition states that the subject cotton should not be regulated by APHIS because it does not present a plant pest risk.

On December 16, 2002, APHIS published a notice in the Federal Register (67 FR 77034-77035, Docket No. 02-092-1) announcing that the Aventis petition and an environmental assessment (EA) were available for public review. This notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject cotton and food products developed from it. APHIS received two comments on the petition and the EA during the 60-day comment period which ended February 14, 2002. The comments were received from a cotton industry organization and a cotton farmer, and both supported nonregulated status for LLCotton25.

LLCotton25 has been genetically engineered to contain a bar gene isolated from Streptomyces hygroscopicus strain ATCC21705. The bar gene encodes phosphinothricin-N-acetyltransferase (PAT), and the PAT enzyme catalyzes the conversion of L-phosphinothricin, the active ingredient in glufosinate, to an inactive form, thus conferring tolerance to the herbicide. Expression of the added genes is controlled in part by gene sequences from the plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. Agrobacterium-mediated gene transfer was used to transfer the added genes into the recipient Coker 312 cotton variety.

LLCotton25 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. This cotton has been field tested since 1999 in the United States under APHIS notifications. In the process of reviewing the notifications for field trials of the subject cotton, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical confinement or isolation, would not present a risk of plant pest introduction or dissemination.


Based on its analysis of the data submitted by Aventis, a review of other scientific data, field tests of the subject cotton, and comments submitted by the public, APHIS has determined that LLCotton25: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become weedy than the non-transgenic parental line or other cultivated cotton; (3) is unlikely to increase the weediness potential for any other cultivated or wild species with which it can interbreed; (4) will not cause damage to raw or processed agricultural commodities; (5) will not harm threatened or endangered species or organisms that are beneficial to agriculture; and (6) should not reduce the ability to control pests and weeds in cotton or other crops. Therefore, APHIS has concluded that the subject cotton and any progeny derived from hybrid crosses with other nontransformed cotton varieties will be as safe to grow as cotton in traditional breeding programs that is not subject to regulation under 7 CFR part 340.

The effect of this determination is that Aventis' LLCotton25 is no longer considered a regulated article under APHIS” regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the subject cotton or its progeny. However, importation of LLCotton25 and seeds capable of propagation are still subject to the restrictions found in APHIS” foreign quarantine notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.

National Environmental Policy Act

An EA was prepared to examine the potential environmental impacts associated with a determination of nonregulated status for Aventis' LLCotton25. The EA was prepared in accordance with (1) the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372). Based on that EA, APHIS has reached a finding of no significant impact (FONSI) with regard to its determination that LLCotton25 and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and FONSI are available from the individual listed under FOR FURTHER INFORMATION CONTACT.

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Done in Washington, DC, this 18th day of March, 2003.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. 03-6798 Filed 3-20-03; 8:45 am]